Public Accessibility of FCOIs on the website
9.0 Duties of the Investigators:
(ii) Institution’s policy on FCOI; and
(iii) Investigator’s responsibilities regarding disclosure of SFIs
4.0 Applicable Regulations:
1.0 Covered Institution:
InflamaCORE, LLC., “Company” or “Institution” is covered under this policy as required by the National Institutes of Health (NIH) and applicable US regulations. It is the responsibility of the Company to Promote Objectivity in all Research performed by or for the company including all research for which Public Health Service, which includes the National Institutes of Health, funding is sought or obtained. Significant Financial Interest (SFI)s include financial interests that are related to an Investigator’s institutional responsibilities. The Company is responsible for determining whether SFI relates to NIH-funded research and if it is a Financial Conflict of Interest (FCOI).
This Policy provides the standards that provide a reasonable expectation that the design, conduct, and reporting of NIH-funded research will be free from bias resulting from Investigator financial conflicts of interest. The Company shall maintain an up-to-date, written, enforced policy that complies with the FCOI regulation and make available via a publicly accessible Web site. The Company and all of its employees shall comply with this Policy and applicable regulations in all research.
The policy governing financial conflict of interest applies to all Investigators of InflamaCORE, LLC. The Company Official is responsible for ensuring implementation of this policy and may suspend all relevant activities until the financial conflict of interest is resolved or other action deemed appropriate by the Company Official is implemented. This regulation applies to any SFI [as defined below] that could directly and significantly affect the design, conduct, or reporting of company research, including NIH-or other Government funded research. This Policy does not apply to Small Business Innovation Research/Small Business Technology Transfer (SBIR/STTR) Phase I applications and grants.
3.0 HHS/NIH Authority:
The Department of Health and Human Services (HHS) may at any time inquire into the Institutional procedures and actions regarding conflicting financial interests in NIH-funded research. The NIH and the HHS have authority that applies before, during, or after an award with regard to any Investigator disclosure of financial interests, regardless of whether or not the disclosure resulted in the Institution’s determination of an FCOI.
Electronic Research Administration (eRA) Commons FCOI Module
The reporting tool for submitting FCOI reports for grants and cooperative agreements is the eRA Commons FCOI Module. This reporting tool is being enhanced and currently allows the Company to:
15.0 Maintenance of Records
The Company shall maintain records of all Investigator disclosures of financial interests and the Institution’s review of, and response to, such disclosures (whether or not a disclosure resulted in the Institution’s determination of FCOI) and all actions under the Institution’s policy or retrospective review, if applicable
12.0 Management Plan:
Any FCOI or non-compliance with this Policy shall be reported to the Responsible Individual. The Responsible Individual shall determine if there was a non-compliance in coordination with the President. The Responsible Individual shall within 120 days of the Institution’s determination of non-compliance, complete a retrospective review of the investigator’s activities and the NIH-funded research project to determine if there was bias in the design, conduct, or reporting of such research. The Responsible Individual shall document the retrospective review.
7.0 Publication of FCOI Policy and Conflicts:
This Policy shall be made available in the “About Us” Section of the Company’s publically assessable web site. It shall be updated as required when changes are made or as specified in the regulation. Additionally, prior to the expenditure of any NIH/HHS funds, the Responsible Individual shall make information concerning FCOIs held by senior/key personnel via the Company’s Web site in the “About Us” Section, and update such information as specified in the regulation.
FCOI training required. Each Investigator must complete training prior to engaging in research related to any NIH-funded grant and at least every four years, and immediately under the designated circumstances:
If bias is found, a Mitigation Report shall be prepared by the Responsible Individual.
The retrospective review and Mitigation Report shall include:
(i) Institution revises its policy in a manner that affects the investigator;
(ii) When an investigator is new to the institution; or
(iii) When the institution finds an Investigator is not in compliance with the Institution’s policy or management plan.
13.0 Application Certification:
The company shall Certify in each application for funding that the Institution:
11.0 Duties of the Responsible Individual:
FCOI training is required of each Investigator:
The President, with the advice and consult of the Responsible Individual, shall have the authority to enforce this Policy. Sanctions, administrative actions, and other actions up to and including termination may be taken to enforce this policy and ensure Investigator compliance.
The President may require that one or more of the following actions be taken in order to manage, reduce, or eliminate a potential Conflict of Interest:
a. Disclosure of Significant Financial Interests, including to the public, human subjects, researchers and other participants and publishers;
b. Monitoring of PHS-funded Research by independent researchers and/or reviewers, disinterested individuals or committees;
c. Disqualification from participation in all or a portion of the PHS-funded Research;
d. Requiring that Significant Financial Interests be divested, restructured, or placed in blind trust;
e. Modification or severance of relationships that create a potential Conflict of Interest;
f. Changing terms of agreement relating to the PHS-funded Research;
g. Requiring that Investigator participation in the recruitment or consent of subjects in human subjects PHS-funded Research be prohibited or restricted;
h. Requiring additional disclosures or actions with respect to matters before the Research Management Team; or
i. Requiring non-participation in any business transactions between the Company and parties to agreements involving sponsored PHS-funded Research.
19.0 Revision of Policies:
This policy shall be reviewed upon changes to the Federal Regulation and revised as appropriate
If results of the retrospective review warrant, update previously submitted FCOI report
14.0 Designated Institutional Official(s); i.e.: Responsible Individual
The company shall:
10.0 Investigator Disclosure of SFI:
The investigator shall disclose any SFI:
To prepare, Institutional Signing Officials must assign FCOI roles to users in eRA Commons.
The Responsible Individual and Controller shall assure that any FCOI is reported on the Web Site prior to the expenditure of any funds under the award and
Within 60 days for any interest that the Institution identifies as conflicting subsequent to the Institution’s initial report under the award
Current requirements, plus annual updates on any previously-identified FCOI for the duration of the research project (including during an extension with or without funds)
The Company shall, within 120 days of the Company’s determination of non-compliance, complete a retrospective review of the investigator’s activities and the NIH-funded research project to determine if there was bias in the design, conduct, or reporting of such research. Institution is required to document the retrospective review.
The Responsible Individual shall work with the Controller to submit the following reports to the NIH:
The following shall be excluded from Significant Financial Interest:
17.0 HHS Authority
The HHS may at any time inquire into the Institutional procedures and actions regarding conflicting financial interests in NIH-funded research. The HHS authority applies before, during, or after an award with regard to any Investigator disclosure of financial interests, regardless of whether or not the disclosure resulted in the Institution’s determination of an FCOI.
Company shall mean InflamaCORE, LLC.
Institution shall mean InflamaCORE, LLC.
Company Official means the individual within the Company that is responsible for the solicitation and review of disclosures of significant financial interests including those of the Investigator’s Family related to the Investigator’s Company responsibilities. For the purposes of this policy, the Company Official is designated as Robert Keane, PhD.
Institutional responsibilities means an Investigator's professional responsibilities on behalf of the Institution, and as defined by the Institution in its policy on financial conflicts of interest, which may include for example: activities such as research, research consultation, teaching, professional practice, institutional committee memberships, and service on panels such as Institutional Review Boards or Data and Safety Monitoring Boards.
Investigator means the project director or principal Investigator and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research funded by the NIH, or proposed for such funding, which may include, for example, collaborators or consultants.
Responsible Individual shall mean that person designated herein.
Senior/key personnel means the PD/PI and any other person identified as senior/key personnel by the Institution in the grant application, progress report, or any other report submitted to the PHS by the Institution under the regulation. (Note: Different definition than the NIH Grants Policy Statement.)
Family means any member of the Investigator’s immediate family, specifically, any dependent children and spouse or domestic partner that qualify as dependents under the Internal Revenue Code definitions.
Public Health Service (“PHS”) means the Public Health Service of the U.S. Department of Health and Human Services, and any components of the PHS to which the authority of the PHS may be delegated. The components of the PHS include, but are not limited to, the Administration for Children and Families, Administration on Aging, Agency for Healthcare Research and Quality, Agency for Toxic Substances and Disease Registry, Centers for Disease Control and Prevention, Federal Occupational Health, Food and Drug Administration, Health Resources and Services Administration, Indian Health Service, National Institutes of Health, and Substance Abuse and Mental Health Services Administration.
Research means a systematic investigation, study, or experiment designed to contribute to generalizable knowledge relating broadly to public health. The term encompasses basic and applied research (e.g., a published article, book or book chapter) and product development (e.g., a diagnostic test or drug).
6.0 Significant Financial Interest (SFI) shall be interpreted as:
(1) A financial interest consisting of one or more of the following interests of the Investigator (and those of the Investigator’s spouse or domestic partner and dependent children) that reasonably appears to be related to the Investigator’s institutional responsibilities:
(i) With regard to any publicly traded entity, a significant financial interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure and the value of any equity interest in the entity as of the date of disclosure, when aggregated, exceeds $5,000. For purposes of this definition, remuneration includes salary and any payment for services not otherwise identified as salary (e.g., consulting fees, honoraria, paid authorship); equity interest includes any stock, stock option, or other ownership interest, as determined through reference to public prices or other reasonable measures of fair market value;
(ii) With regard to any non-publicly traded entity, a significant financial interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure, when aggregated, exceeds $5,000, or when the Investigator (or the Investigator’s spouse or dependent children) holds any equity interest (e.g., stock, stock option, or other ownership interest); or
(iii) Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests.
(2) Investigators also must disclose the occurrence of any reimbursed or sponsored travel (i.e., that which is paid on behalf of the Investigator and not reimbursed to the Investigator so that the exact monetary value may not be readily available), related to their institutional responsibilities, provided, however, that this disclosure requirement does not apply to travel that is reimbursed or sponsored by excluded sources provided in regulation.
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